Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 233-215-5 | CAS number: 10081-67-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute oral LD50 >2000 mg/kg.
Acute dermal LD50 >2000 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 November 2007 to 05 December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD test guidelines in compliance with GLP and reported with a valid GLP certificate.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species: RatsStrain: WistarWeight: 140 – 160gNumber and sex: 3 females, 3 males – use due to limit test.Source: Accredited Breeding Velaz Prague CZIdentification: The animals were housed individually in cages after application. They were marked by number placed on the cages.Husbandry:Housing: Animals were housed in cage on bedding in groups by 5 in room No. 132 of experimental animal house. After application they were house individually. Environment: Environmental controls for the animal room will be set to maintain 22 ± 2°C, a relative humidity of 55 ± 5%. The temperature and relative humidity of air will be registered and the records maintained in animal house. A minimum of 10 air changes/air, and artificial light regime 12h light/12h dark. The sanitation was made according to standard operation procedure. Food and water: A standard certified laboratory diet (supplier Top Dovo Dobrá Voda) was served ad libitum and unlimited supply of drinking water. The diet was routinely analysed by the manufacturer for nutritional components and environmental contaminants. Acclimatisation: 5 days before the beginning of treatment.
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- Vehicle Article: Olivae oleum raffinatumBatch number: L706203 (G. Heess)Quality control protocol No 625/539/64/2007
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 females & 3 males
- Control animals:
- no
- Details on study design:
- Preparation of doses: Application dose 2000 mg/kg for animals was prepared shortly prior to administration. To precise weighed test article was gradually added vehicle. Doses administration manner: The test article was applied in a single dose using a stomach tube. It was administered in uniform volume 10 ml/kg body weight. Animals were fasted prior to dosing (food but not water were withheld overnight). Following the period of fasting the animals were weighed and the test article administered. After the test article was administered food had been withheld for a further 3-4 hours. Animals dosage: On the base of literature data we use dose 2000 mg/kg for limit test. We applied 3 females and three males by dose 2000 mg/kg. Subsequently, observations of effects and death were made. Clinical observations: Animals were observed individually after dosing at least once during the forst 30 minutes, periodically during the first 24 hours, with special attention given during the first 4 hours, and daily thereafter, for a total of 14 days. All observations were systematically recorded, with individual records being maintained for each animal. We used separate OECD Guidance Document for assessing of clinical signs and conditions associated with pain, suffering and impending death.Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Bodyweight: Individual bodyweights of animals were determined shortly before the test article was administered and weekly thereafter. Weight changes after first and second week after application were calculated and recorded. Pathology: All test animals were subjected to gross necropsy. All gross pathological changes were recorded for each animal. Animals to be sacrificed were anesthetised, extinguished and necropsied according to standard procedures, euthanasia and autopsy of animal.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died in either the first 4 hours or in the 14 days observation period.
- Clinical signs:
- other: other: None of the animals displayed any toxic symptoms either in the first 4 hours or in the 14 days observation period.
- Gross pathology:
- Pathology findings not detailed in the study report.
- Other findings:
- No further findings specified.
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The LD50 of DUSANTOX 86 after single oral application is above limit dose of 2000 mg/kg.
- Executive summary:
The test article DUSANTOX 86 was applied to 3 rats females and 3 rats males in a single oral dose 2000 mg/kg. Dose 2000 mg/kg was selected for a limit test due to presupposed low toxicity. Subsequently, observations of effects and death were made. Death and/or any toxicity symptoms did not occur. The experiment determined that the LD50 is above limit dose of 2000 mg/kg and DUSANTOX 86 fulfils conditions of category 5 “Unclassified” according to GHS. There was no observed difference in sensitivity on tested article between sexes.
No classification is applicable.
Reference
Tab. 1
Sex: females Dose: 2000 mg/kg
Animal no. | Weight [g] | Weight [g] | Weight | Weight [g] | Weight | Appl. Vol. | Response |
Initial | After 1 week | Change [g] | After 2 weeks | Change [g] | ml | ||
1 | 170 | 200 | 30 | 205 | 5 | 1.7 | O |
2 | 170 | 200 | 30 | 207 | 5 | 1.7 | O |
3 | 170 | 190 | 20 | 195 | 5 | 1.7 | O |
Tab. 2
Sex: males Dose: 2000 mg/kg
Animal no. | Weight [g] | Weight [g] | Weight | Weight [g] | Weight | Appl. Vol. | Response |
Initial | After 1 week | Change [g] | After 2 weeks | Change [g] | ml | ||
4 | 240 | 265 | 25 | 290 | 25 | 2.4 | O |
5 | 220 | 250 | 30 | 270 | 20 | 2.2 | O |
6 | 210 | 240 | 30 | 265 | 25 | 2.1 | O |
Tab. 3
Sex: females Dose: 2000 mg/kg
Animal no. | Signs of toxicity | |||
Immediately | After 30 min. | After 1 hour | After 4 hours | |
1 | w/s | w/s | w/s | w/s |
2 | w/s | w/s | w/s | w/s |
3 | w/s | w/s | w/s | w/s |
Tab.4
Sex: males Dose: 2000 mg/kg
Animal no. | Signs of toxicity | |||
Immediately | After 30 min. | After 1 hour | After 4 hours | |
4 | w/s | w/s | w/s | w/s |
5 | w/s | w/s | w/s | w/s |
6 | w/s | w/s | w/s | w/s |
w/s – without symptoms
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 September 2007 to 29 November 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with draft OECD test guideline in compliance with GLP and reported with a valid GLP certificate. Klimish 2 reliability assigned due to the fact that the study is still a draft guideline and not formally accepted.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- Deviations:
- yes
- Remarks:
- males and females where used where the guideline only recommends use of females
- Principles of method if other than guideline:
- OECD Guidelines for the Testing of Chemicals are periodically reviewed in the light of scientific progress and animal welfare considerations. The original acute Dermal Toxicity Guideline TG 402 was adopted in 1987. Development of a dermal Fixed Dose Procedure (FDP) was considered appropriate, following adoption of the revised Oral FDP, OECD Guideline 420 and deletion of OECD Guideline 401 in December 2001. This FDP guideline will allow the use of a series of fixed doses for the determination of acute dermal toxicity in only one sex (usually females). This study utilises both males and females. This is not expected to impact on the findings of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species: RatsStrain: WistarWeight: 140 – 160gNumber and sex: 3 females, 3 males – we used only 3 females and 3 males because of low acute toxicity of test article we could use limit test.Source: Accredited Breeding Velaz Prague CZIdentification: The animals were housed individually in cages after application. They were marked by number placed on the cages.Husbandry:Housing: Animals were housed in cage on bedding in groups by 5 in room No. 133 of experimental animal house. After application they were house individually. Environment: Environmental controls for the animal room will be set to maintain 22 ± 2°C, a relative humidity of 55 ± 5%. The temperature and relative humidity of air will be registered and the records maintained in animal house. A minimum of 10 air changes/air, and artificial light regime 12h light/12h dark. The sanitation was made according to standard operation procedure. Food and water: A standard certified laboratory diet (supplier Top Dovo Dobrá Voda) was served ad libitum and unlimited supply of drinking water. The diet was routinely analysed by the manufacturer for nutritional components and environmental contaminants. Acclimatisation: 5 days before the beginning of treatment.
- Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- Approximately 24 hours before dose application, fur was removed from the dorsal area of the trunk of the test animals by clipping and shaving. The test article was applied uniformly as much of the area was covered with as thin and uniforms a film as possible on over an area which was approximately 10% of a total body surface. Test article was held in contact with the skin with a porous gauze patch covered with nonpermeabile folio by means of a semi-occlusive dressing and non-irritating tape throughout a 24-hours exposure period. At the end of the exposure period residual test article was removed, using water, without altering the existing response or integrity of the epidermis.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- Animal dosage: On the base of literature data a dose level of 2000 mg/kg for a limit test was selected. This dose was applied to 3 females and three males by dose 2000 mg/kg. Subsequently, observations of effects and death were made. Clinical observations: Animals were observed individually after dosing at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first 3 hours, and daily thereafter, for a total of 14 days. All observations were systematically recorded, with individual records being maintained for each animal. Clinical signs and conditions associated with pain, suffering and impending death are described in detail in a separate OECD Guidance Document. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Bodyweight: Individual bodyweights of animals were determined shortly before the test article was administered and weekly thereafter. Weight changes after first and second week after application were calculated and recorded. Pathology: All test animals (including those that died during the test) were subjected to gross necropsy. All gross pathological changes were recorded for each animal. Animals to be sacrificed were anesthetised, extinguished and necropsied according to standard procedures, euthanasia and autopsy of animal
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died in the first 4 hours or in the 14 days observation period.
- Clinical signs:
- other: other: None of the animals displayed any toxic symptoms in the first 4 hours or in the 14 days observation period.
- Gross pathology:
- None of animals displayed any pathological lesions.
- Other findings:
- Well defined or slight erythema was observed at the site of application; this subsequently healed within the study period.
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The LD50 of DUSANTOX 86 after single oral application is above limit dose of 2000 mg/kg.
- Executive summary:
The test article DUSANTOX 86 was applied to 3 rats females and 3 rats males in a single dermal dose 2000 mg/kg.Dose 2000 mg/kg was selected for a limit test due to presupposed low toxicity. Subsequently, observations of effects and death were made. Death and/or any toxicity symptoms did not occur.The experiment determined that the LD50 is above limit dose of 2000 mg/kg and DUSANTOX 86 fulfils conditions of category 5 “Unclassified” according to GHS. There was no observed difference in sensitivity on tested article between sexes.
No classification is applicable.
Reference
Tab. 1
Sex: females Dose: 2000 mg/kg
Animal no. | Weight [g] | Weight [g] | Weight | Weight [g] | Weight | Appl. Vol. | Response |
Initial | After 1 week | Change [g] | After 2 weeks | Change [g] | ml | ||
1 | 160 | 170 | 10 | 180 | 10 | 0.400 | O |
2 | 170 | 180 | 10 | 190 | 10 | 0.425 | O |
3 | 170 | 170 | 0 | 180 | 10 | 0.425 | O |
Tab. 2
Sex: males Dose: 2000 mg/kg
Animal no. | Weight [g] | Weight [g] | Weight | Weight [g] | Weight | Appl. Vol. | Response |
Initial | After 1 week | Change [g] | After 2 weeks | Change [g] | ml | ||
4 | 220 | 230 | 10 | 255 | 25 | 0.550 | O |
5 | 210 | 250 | 40 | 275 | 25 | 0.525 | O |
6 | 240 | 250 | 10 | 265 | 15 | 0.600 | O |
Tab. 3
Sex: females Dose: 2000 mg/kg
Animal no. | Signs of toxicity | |||
Immediately | After 30 min. | After 1 hour | After 4 hours | |
1 | w/s | w/s | w/s | w/s |
2 | w/s | w/s | w/s | w/s |
3 | w/s | w/s | w/s | w/s |
Tab.4
Sex: males Dose: 2000 mg/kg
Animal no. | Signs of toxicity | |||
Immediately | After 30 min. | After 1 hour | After 4 hours | |
4 | w/s | w/s | w/s | w/s |
5 | w/s | w/s | w/s | w/s |
6 | w/s | w/s | w/s | w/s |
w/s – without symptoms
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral
The test article DUSANTOX 86 was applied to 3 rats females and 3 rats males in a single oral dose 2000 mg/kg. Dose 2000 mg/kg was selected for a limit test due to presupposed low toxicity. Subsequently, observations of effects and death were made. Death and/or any toxicity symptoms did not occur. The experiment determined that the LD50 is above limit dose of 2000 mg/kg and DUSANTOX 86 fulfils conditions of category 5 “Unclassified” according to GHS. There was no observed difference in sensitivity on tested article between sexes.
No classification is applicable.
Dermal
The test article DUSANTOX 86 was applied to 3 rats females and 3 rats males in a single dermal dose 2000 mg/kg.Dose 2000 mg/kg was selected for a limit test due to presupposed low toxicity. Subsequently, observations of effects and death were made. Death and/or any toxicity symptoms did not occur.The experiment determined that the LD50 is above limit dose of 2000 mg/kg and DUSANTOX 86 fulfils conditions of category 5 “Unclassified” according to GHS. There was no observed difference in sensitivity on tested article between sexes.
No classification is applicable.
Justification for selection of acute toxicity – oral endpoint
Effect level determined using OECD guideline 423
Justification for selection of acute toxicity – inhalation endpoint
No data available. The substance is of low volatility and limited particle size, and is not utilised in exercises where dusts or aerosols could be generated. As a result, inhalation is not considered to be a primary route of exposure.
Justification for selection of acute toxicity – dermal endpoint
Effect level determined using OECD guideline 434.
Justification for classification or non-classification
The above studies have all been ranked reliability 1 or 2 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP but the dermal toxicity study is conducted to a draft OECD Guideline. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the CLP Regulation (EC No 1272/2008). No classification for acute effects is therefore required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)